36
Participants
Start Date
December 31, 2009
Primary Completion Date
June 30, 2013
Study Completion Date
June 30, 2013
Everolimus
One tablet containing 0.25, 0.5mg or 0.75 mg. Initially 2 mg/day. Afterwards based on blood level (target 6-10 ng/mL)
Tacrolimus (FK506)
Capsules 0.5 mg, 1 mg. Dosing according to blood level.
Basiliximab
One vial containing 20 mg lyophilisate. 2 x 20 mg \[day 0 (2 hrs prior to Tx) and day 4 post Tx\] to be applied as 10 sec. bolus injection, i.v.
Enteric Coated Mycophenolate Sodium (EC-MPS)
One tablet containing 180 mg or 360 mg. 1440 mg/day (2x720 mg). If tolerated, dose reduction due to side effectis were possible (min. dose at BL@: 720 mg/day)
Corticosteroids
Used according to Israeli standards. A minimum dose of 5mg \[prednisone, or equivalent, was used throughout the study period.
Novartis Investigative Site, Haifa
Novartis Investigative Site, Petah Tikva
Novartis Investigative Site, Tel Aviv
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY